510(k) · Cleared
ClearedHorizon Epikeratome Disposable Microkeratome System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hawken Industries · HNO Keratome, Ac-Powered
Cleared on Mar 23, 2006 as substantially equivalent to K981155 (Hawken Industries, 1998) and 1 other predicate after a 161-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Mar 23, 2006
- Review
- 161 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K843646 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K843646 | Steinway Micro-Kerato-Trephine | Steinway Instrument Co., Inc. | 1985 | — |
| −1 | K981155 | Flapmaker Disposable Microkeratome | Hawken Industries | 1998 | — |
| 0 (this device) | K052891 | Horizon Epikeratome Disposable Microkeratome System | Hawken Industries | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HNO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981155 | Flapmaker Disposable MicrokeratomeSummary page 1…omne Classification Name: Keratome, A-C powered (3) Equivalent legally-marketed devices: The predicate devices for the Horizon Epikeratome are Hawken Flapmaker, K98 1155, and the Norwood Abbey Centurion, KO051486. (4) Description The device consists of a control console and disposable HO… | 1998 |
| * | K051486 | Norwood Abbey Centurion Ses EpikeratomeSummary page 1…C powered (3) Equivalent legally-marketed devices: The predicate devices for the Horizon Epikeratome are Hawken Flapmaker, K98 1155, and the Norwood Abbey Centurion, KO051486. (4) Description The device consists of a control console and disposable HORIZON EPIKERATOMETm microkeratome hand piec… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 13.6 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K981155.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNO
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HNO
Too few HNO 510(k)s in any year since 2007 to give a median.
Recalls per year · HNO
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNO
7in 2024
MAUDE reports naming product code HNO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 32 |
| 2008 | 1 | — | 2 | 31 |
| 2009 | 1 | — | 0 | 85 |
| 2010 | 0 | — | 0 | 84 |
| 2011 | 0 | — | 4 | 90 |
| 2012 | 0 | — | 0 | 100 |
| 2013 | 0 | — | 0 | 353 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 966 |
| 2016 | 0 | — | 0 | 1,397 |
| 2017 | 1 | — | 0 | 2,112 |
| 2018 | 1 | — | 0 | 2,265 |
| 2019 | 0 | — | 0 | 816 |
| 2020 | 0 | — | 0 | 405 |
| 2021 | 0 | — | 0 | 72 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Horizon EpikeratomeTM is indicated when it is desired to use a single-use microkeratome system that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter and for the separation of the epithelium from the cornea for subsequent surgical procedures on denuded cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052891: Horizon Epikeratome Disposable Microkeratome System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052891
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026